FDA 483 - Scinopharm Taiwan Ltd - April 01, 2022

ScinoPharm Taiwan Ltd, a drug substance and sterile drug manufacturer in Shan-Hua, Taiwan, was cited for two observations during an FDA inspection from March 21 to April 1, 2022. The firm failed to follow proper stock rotation for components, leading to out-of-specification drug product, and also failed to re-qualify critical equipment used for sterility assurance and drug product manufacturing. These issues indicate deficiencies in quality control and equipment management.